Changing Developmental Trajectories Through Early Treatment
|ClinicalTrials.gov Identifier: NCT01985022|
Recruitment Status : Recruiting
First Posted : November 15, 2013
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Behavioral: PII with IES Behavioral: IES||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: PII with IES
The treatment condition that this group receives is PII with IES for 9 months.
Behavioral: PII with IES
This is an individualized parent-implemented intervention (PII) offered weekly to teach parents how to embed strategies to support social communication skills for 25 hours a week within everyday routines, activities, and places for 9 months. In addition parent will receive twice weekly the IES condition of the study.
The treatment condition that this group receives is IES for 9 months.
Parents will receive information, education, and support. They once a week for 75 minutes.
- Child's social communication [ Time Frame: End of treatment (9 months) ]Standardized measure of child's social communication: Communication and Symbolic Behavior Scales (CSBS)
- Child's Autism Symptoms [ Time Frame: End of treatment (9 months) ]Standardized Measure of autism symptoms: Autism Diagnostic Observation Schedule (ADOS).
- Child's Developmental Level [ Time Frame: End of treatment (9 months) ]Standardized measure of child development: Mullen Scales of Early Learning (MSEL)
- Child's Adaptive Behavior [ Time Frame: End of treatment (9 months) ]Standardized measure of adaptive behavior: Vineland Adaptive Behavior Scales (VABS-II)
- Parent Report [ Time Frame: End of treatment (9 months) ]Parent measures of family functioning, daily hassles, and treatment satisfaction.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985022
|Contact: Nathan Call, PhDemail@example.com|
|Contact: Amy Wetherby, PhD|
|United States, Georgia|
|Marcus Autism Center||Recruiting|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Nathan Call, PhD||Emory University, Marcus Autism Center, Children's Healthcare of Atlanta|
|Study Director:||Amy Wetherby, Ph.D.||Florida State University|